Dr DBA Narayana, an eminent pharmacist and member of the Mashelkar Committee, said that it is high time the Central Drugs Standard Control Organization (CDSCO) is rechristened as the Central Drug Safety and Standards Administration (CDSSA) by the Union health ministry as this would transform it into an effective network of drug standard enforcement.

In fact, the Mashelkar Committee’s comprehensive recommendations called to restructure and refurbish the CDSCO and replace it with CDSSA. It urged for creation of small advisory committees to support the CDSSA with representatives from the Central Scientific & Industrial Research (CSIR), Department of Biotechnology (DBT), Department of Science & Technology (DST), Department of Health Research (DHR), and Indian Council of Medical Research (ICMR), to advise the Drugs Controller General of India (DCGI) and the CDSSA, Dr Narayana told Pharmabiz.

The CDSSA should be in addition to the existing Drug Technical Advisory Board (DTAB), which has been there for over 60 years with more representatives from scientific and research areas which was also mentioned in the Mashelkar Committee, he added.

“Now it is difficult to understand why the recommendations of the  Mashelkar Committee were ignored and the government wanted to create a new body called Central Drugs Authority (CDA) with drug control administration being a part of it. It creates a total confusion and further weakens the functioning of the Drug Control Authority by the DCGI. Although the issue was examined by a Parliamentary Standing Committee during the Drugs and Cosmetics (Amendment) 2007, its recommendations did not support a CDA independent of DCGI. Therefore it is crucial to review, even the proposed CDA Bill which is misleading, he said.

It is now accepted that evaluations of drugs and cosmetics is a highly scientific and technical job. This is because it relates to evaluation of quality, safety, toxicology, stability and efficacy, with stringent enforcement of drug regulations. It is important to make provisions that prescribe appointment of scientifically and technically qualified professional from pharmacy/pharmaceutical sciences/medical qualifications with pharmacology specializations, and person with impeccable integrity to head the Central and State Drug Control Administration.

Thus what needs to be created without any delay is a strong, well equipped, and professionally managed CDSCO headed by DCGI, which may be called CDSSA, he said.

It is a decade since Mashelkar Committee submitted its report in 2003. The purpose of this whole exercise was to expand the scope of the existing CDSCO to be able to maximize the unprecedented global scientific advances by suitably improving the technical infrastructure of the regulatory authority. Although it has been examined by many expert teams and especially the Mashelkar Committee clearly recommended for the CDSSA, said Dr Narayana.